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| ID | Type | Description | Link |
|---|---|---|---|
| FWA00015357 | Registry Identifier | HHS, Human Protections Administrator | |
| IRB00009424 | Registry Identifier | HHS, IRB | |
| IORG0007849 | Registry Identifier | HHS, IORG | |
| NPI-1831468511 | Registry Identifier | HHS, Health Care Provider Individual | |
| NPI-1023387701 | Registry Identifier | HHS, Health Care Provider Organization | |
| IND 179135 | Registry Identifier | FDA, IND |
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| Name | Class |
|---|---|
| UnitedHealthcare | OTHER |
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Conducting an initial small, controlled clinical pharmacology trial to assess for therapeutic biologics activity (proof-of-concept) that suggests the potential for clinical benefit of HIV (+) patients
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Assess for therapeutic biologics activity (proof-of-concept) | Experimental | Therapeutic Biological Product Mix activity - HIV GP160 0.1 mg x 1 mL add into BCG Organism 50 MG |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HIV Therapeutic Biologic Mix - HIV GP160 plus BCG Vaccine Mix for percutaneous use | Biological |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of HIV (+) Participants: |
| Duration up to 4 weeks |
| Rate of Positive HIV nucleic acid: |
| Duration up to 4 weeks |
| Rate of Negative HIV nucleic acid: |
| Duration up to 4 weeks |
| 20 HIV (+) Participants with IGRA blood test with HIV antigens | - Positive IGRA blood test with HIV GP160 antigen after percutaneous use 3 weeks | Duration up to 4 weeks |
| 20 HIV (+) Participants with IGRA blood test with TB antigens |
| Duration up to 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| HAN XU, MD/PhD/FAPCR | Medicine Invention Design Incorporation - IRB00009424 | Study Chair |
| HAN XU, MD/PhD/FAPCR | Medicine Invention Design Incorporation - IORG0007849 | Study Director |
| HAN XU, MD/PhD/FAPCR | Medicine Invention Design Incorporation - NPI 1023387701 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medicine Invention Design Incorporation - IORG0007849 - NPI 1023387701 | Rockville | Maryland | 20853 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27102489 | Background | Netea MG, Joosten LA, Latz E, Mills KH, Natoli G, Stunnenberg HG, O'Neill LA, Xavier RJ. Trained immunity: A program of innate immune memory in health and disease. Science. 2016 Apr 22;352(6284):aaf1098. doi: 10.1126/science.aaf1098. Epub 2016 Apr 21. | |
| 32132681 | Background | Netea MG, Dominguez-Andres J, Barreiro LB, Chavakis T, Divangahi M, Fuchs E, Joosten LAB, van der Meer JWM, Mhlanga MM, Mulder WJM, Riksen NP, Schlitzer A, Schultze JL, Stabell Benn C, Sun JC, Xavier RJ, Latz E. Defining trained immunity and its role in health and disease. Nat Rev Immunol. 2020 Jun;20(6):375-388. doi: 10.1038/s41577-020-0285-6. Epub 2020 Mar 4. |
| Label | URL |
|---|---|
| FWA00015357 | View source |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 12, 2025 | Sep 23, 2025 |
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Single Usage / Single Dosage
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Open Label
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|
| IRB00009424 | View source |
| IORG0007849 | View source |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 12, 2025 | Oct 1, 2025 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 12, 2025 | Sep 23, 2025 | ICF_002.pdf |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D012897 | Slow Virus Diseases |
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